NCT06653517

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Neoadjuvant BRAFV600E-Targeted Therapy for Conventional Ameloblastoma of the Jaw:A Single-Arm Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the tumor shrinkage effect of preoperative targeted induction therapy with dabrafenib and trametinib in patients with conventional ameloblastoma harboring the BRAF V600E mutation. The study will assess the proportion of cases where mandibular continuity cannot be preserved that can be converted to cases where mandibular continuity is preserved, as well as the proportion of cases where complete resection is initially not feasible that become resectable.

Detailed description

PRIMARY OBJECTIVES: Ⅰ. To observe the proportion of patients with ameloblastoma requiring mandibular segmental resection at initial diagnosis who can convert to mandibular preservation surgery after preoperative induction therapy with dabrafenib and trametinib. Ⅱ.To observe the proportion of cases initially deemed non-radical resectable Surgery that become resectable SECONDARY OBJECTIVES: Ⅰ. Radiological response Ⅱ. Pathological response Ⅲ. Local recurrence-free survival(LRFS) Ⅳ.Feasibility and safety in this patient population OUTLINE: Dabrafenib: Dosage: 150 mg twice daily (total daily dose of 300 mg). Administration: Must be taken in combination with trametinib until disease progression or intolerable toxicity occurs. Administer at least 1 hour before or 2 hours after a meal, with approximately 12 hours between doses. Take at the same time each day. If a dose is missed and less than 6 hours remain until the next dose, the missed dose should not be taken. When used in combination with trametinib, take trametinib once daily at the same time as the morning or evening dose of dabrafenib. Do not open, crush, or break the capsules. Trametinib: Dosage: 2 mg once daily orally, in combination with dabrafenib, until disease progression or intolerable toxicity occurs. Administration: Administer at least 1 hour before or 2 hours after a meal. Take at the same time each day. If a dose is missed, it should be taken no later than 12 hours before the next scheduled dose. If less than 12 hours remain until the next dose, the missed dose should not be taken. When used in combination with dabrafenib, take trametinib once daily at the same time as the morning or evening dose of dabrafenib. Do not chew or crush the tablets. Treatment Cycle: Cycle Length: Each cycle lasts 30 days. Initial Follow-Up: Follow-up after each of the first two cycles with a consultation, physical examination, imaging studies, and relevant laboratory tests to evaluate drug toxicity, safety, and tumor shrinkage rate. Adjustment and Transition to Surgery: Toxicity Management: If intolerable drug toxicity or adverse reactions occur that cannot be managed by dose adjustment, discontinue treatment immediately and switch to traditional surgical treatment. Post Two-Cycles Evaluation: After the first two cycles, if intolerable adverse reactions persist or the tumor continues to progress despite dose adjustments, switch to traditional surgical treatment. If the tumor does not progress, continue long-term medication. Long-Term Treatment Follow-Up: Follow-Up Schedule: Conduct follow-up evaluations every two cycles, including consultations, physical examinations, imaging studies, and relevant laboratory tests to evaluate drug toxicity, safety, and tumor shrinkage rate. Criteria for Surgery: If tumor shrinkage reaches a plateau or the patient meets the criteria for mandibular preservation surgery, and the surgical plan is confirmed independently by at least two chief physicians in the department, record this in the case report form and discontinue the medication in preparation for scheduled surgery.

Conditions

• Ameloblastoma
• BRAF V600E Mutation Positive

Interventions

Type	Name	Description
DRUG	Dabrafenib	Dosage: 150 mg orally, twice daily (total daily dose of 300 mg) Administration: Administer at approximately 12 hours apart. Take at the same time each day. If a dose is missed and less than 6 hours remain until the next dose, skip the missed dose. Do not open, crush, or break the capsules. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.
DRUG	Trametinib	Dosage: 2 mg orally, once daily Administration: Administer at least 1 hour before or 2 hours after a meal. Take at the same time each day. If a dose is missed, it should be taken no later than 12 hours before the next scheduled dose; otherwise, skip the missed dose. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

1 site across 1 country: China